Opioid-Free vs Opioid-Based Anesthesia for Nasal Surgeries (Dex/Lido/Fent)

Benha University

Status and phase: Completed; Phase 3

Conditions: Postoperative Pain

Treatments: Drug: dexmedetomidine and lignocaine infusion; Drug: Fentanyl infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT07350668

ms32-12-2024

Details and patient eligibility

About

The goal of this clinical trial is to evaluate and compare the efficacy, onset, duration of action, analgesic effect, and side effects of opioid-free anesthesia using dexmedetomidine and lignocaine versus conventional opioid-based anesthesia using fentanyl in patients undergoing nasal surgeries, including functional endoscopic sinus surgery (FESS) and septoplasty. The main questions it aims to answer are:

• What is the effect of opioid-free anesthesia vs opioid-based anesthesia on VAS score ?
• What is the effect of opioid-free anesthesia vs opioid-based anesthesia on postoperative complications including nausea and vomiting , postoperative Ramsay sedation score, amount of rescue analgesia , hemodynamic stability and patient satisfaction ? patients will be divided into two equal groups:
• Group OBA (Opioid-Based Anesthesia): Consisting of 30 participants, this group will receive intravenous fentanyl at a dose of 2 mcg.kg-1 three minutes prior to induction, followed by a fentanyl infusion at 0.5 mcg.kg-¹.h-¹ during the intraoperative period.
• Group OFA (Opioid-Free Anesthesia): Comprising 30 participants, this group will receive dexmedetomidine at a dose of 1 mcg.kg-1 via intravenous infusion over 10 minutes prior to induction, followed by a continuous infusion of 0.6 mcg.kg-¹.h-¹ throughout the surgery. Intravenous lignocaine at 1.5 mg.kg-1 will be administered three minutes prior to induction, followed by an intraoperative infusion at 1.5 mg.kg-¹.h-¹.

Enrollment: 60 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients between the ages of 18 and 60, scheduled to undergo elective nasal surgeries.
• ASA (American Society of Anesthesiologists) physical status I-II.
• Patients who provide written informed consent to participate in the study.

Exclusion criteria

• ASA III or above.
• Patients with a history of opioid dependence or chronic pain conditions requiring long-term opioid therapy.
• Patients with multiorgan failure, unstable hemodynamics prior to surgery, or scheduled for emergency surgery.
• Pregnant or lactating women.
• Patients with a history of severe asthma or those taking preoperative alpha-blockers.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

dex and lido

Active Comparator group

Description:

this group will receive dexmedetomidine at a dose of 1 mcg.kg-1 via intravenous infusion over 10 minutes prior to induction, followed by a continuous infusion of 0.6 mcg.kg-¹.h-¹ throughout the surgery. Intravenous lignocaine at 1.5 mg.kg-1 will be administered three minutes prior to induction, followed by an intraoperative infusion at 1.5 mg.kg-¹.h-¹.

Treatment:

Drug: dexmedetomidine and lignocaine infusion

Fent

Active Comparator group

Description:

this group will receive intravenous fentanyl at a dose of 2 mcg.kg-1 three minutes prior to induction, followed by a fentanyl infusion at 0.5 mcg.kg-¹.h-¹ during the intraoperative period.

Treatment:

Drug: Fentanyl infusion